MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-06 for RUSCH HURST ESOPHAGEAL BOUGIE 215534 manufactured by Teleflex Medical.
[2068692]
The event is reported as: a doctor accidently cut the bougie and the contents spilled into the patient. It is reported that the patient condition is fine. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9283129]
Method: complaint history review. Results: a complaint history review for the catalog number and family of products was reviewed from (b)(4) 2010 to (b)(4) 2011. No complaints were received in this range with the same issue. Conclusions: user error caused the event. Incorrect use of device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2011-00220 |
| MDR Report Key | 2147060 |
| Report Source | 05,06 |
| Date Received | 2011-06-06 |
| Date of Report | 2011-05-23 |
| Date of Event | 2011-05-23 |
| Date Mfgr Received | 2011-05-23 |
| Date Added to Maude | 2012-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH HURST ESOPHAGEAL BOUGIE |
| Generic Name | ESOPHAGEAL BOUGIE |
| Product Code | KCD |
| Date Received | 2011-06-06 |
| Model Number | NA |
| Catalog Number | 215534 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-06 |